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Regulatory Oversight › New Guidance › Regulatory Agenda

A&O Shearman

FCA to launch new and improved Handbook website

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The UK Financial Conduct Authority (FCA) has announced its plan to launch a new and improved FCA Handbook website as part of its five-year strategy to enhance regulatory efficiency...more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

King & Spalding on

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Troutman Pepper Locke

New Jersey AG Platkin Announces New Guidance on AI Use

Troutman Pepper Locke on

On January 9, New Jersey Attorney General (AG) Matthew J. Platkin and the Division on Civil Rights (DCR) launched a new Civil Rights and Technology Initiative aimed at addressing the potential for discrimination and bias...more

Cadwalader, Wickersham & Taft LLP

First Attempt to Regulate Spot Digital Asset Activities

Cadwalader, Wickersham & Taft LLP on

On March 29, the National Futures Association (“NFA”) promulgated Compliance Rule 2-51, setting forth Requirements for Members and Associates Engaged in Activities Involving Digital Asset Commodities, which includes both...more

Moore & Van Allen PLLC

NYDFS Releases Stablecoin Guidance for NYDFS-regulated Institutions

Moore & Van Allen PLLC on

On June 8, 2022, the New York State Department of Financial Services (“NYDFS”) released industry guidance applicable to U.S. dollar-backed stablecoins issued by NYDFS-regulated entities (the “Guidance”)...more

Morgan Lewis - As Prescribed

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

Baker Donelson on

Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

Skadden, Arps, Slate, Meagher & Flom LLP

SEC Staff Issues CF Disclosure Guidance on Confidential Treatment Requests

Skadden, Arps, Slate, Meagher & Flom LLP on

In December 2019, the Division of Corporation Finance (Staff) of the U.S. Securities and Exchange Commission issued new "CF Disclosure Guidance: Topic No. 7" (Guidance) regarding confidential treatment requests pursuant to...more

Hogan Lovells

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

Hogan Lovells on

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. ...more

Hogan Lovells

NRC Publishes Draft Guidance on Advanced Reactor Licensing Basis Development

Hogan Lovells on

The US Nuclear Regulatory Commission (NRC) in early May issued a notice seeking comments on a new draft regulatory guide impacting advanced reactor licensing. ...more

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